Cardiovascular Disease
Conditions
Brief summary
The objective of the SECURE Study is to actively gather additional information on the use of the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.
Interventions
None listed
Sponsors
Elutia Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With ECM Related Adverse Events | Participants were followed for an average of 235.0 days. | ECM related adverse events were collected at all study visits. |
| Number of Participants With Major Pocket Infections | Participants were followed for an average of 235.0 days. | Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CanGaroo Data collection for information on the use of CorMatrix CanGaroo ECM Envelope | 1,025 |
| Total | 1,025 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Change in Provider | 5 |
| Overall Study | Death | 6 |
| Overall Study | Explant | 2 |
| Overall Study | Hospitalization | 1 |
| Overall Study | Insurance | 2 |
| Overall Study | Lost to Follow-up | 88 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Relocation | 3 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | CanGaroo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 768 Participants |
| Age, Categorical Between 18 and 65 years | 257 Participants |
| Age, Continuous | 71.9 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 990 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| IV Antibiotic Used Prior to Procedure No | 37 Participants |
| IV Antibiotic Used Prior to Procedure Unknown | 50 Participants |
| IV Antibiotic Used Prior to Procedure Yes | 938 Participants |
| Pre-Procedure Temporary Pacing No | 823 Participants |
| Pre-Procedure Temporary Pacing Unknown | 134 Participants |
| Pre-Procedure Temporary Pacing Yes | 68 Participants |
| Procedure Types CRT-D Replacement | 71 Participants |
| Procedure Types CRT-P Replacement | 4 Participants |
| Procedure Types De Novo CRT-D | 93 Participants |
| Procedure Types De Novo CRT-P | 27 Participants |
| Procedure Types De Novo ICD | 158 Participants |
| Procedure Types De Novo Pacemaker | 324 Participants |
| Procedure Types Downgrad CRT-D to ICD | 1 Participants |
| Procedure Types ICD Replacement | 71 Participants |
| Procedure Types Lead Revision/Replacement Only | 36 Participants |
| Procedure Types Pacemaker Replacement | 122 Participants |
| Procedure Types Pocket Revision Only | 10 Participants |
| Procedure Types Upgrade ICD to CRT-D | 47 Participants |
| Procedure Types Upgrade Pacemaker to CRT-D | 27 Participants |
| Procedure Types Upgrade Pacemaker to CRT-P | 21 Participants |
| Procedure Types Upgrade Pacemaker to ICD | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 17 Participants |
| Race (NIH/OMB) Black or African American | 175 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) White | 797 Participants |
| Region of Enrollment United States | 1025 participants |
| Risk Factors for Infection 2 or More Risk Factors | 678 Participants |
| Risk Factors for Infection 3 or More Leads | 28 Participants |
| Risk Factors for Infection Chronic Steroid Use | 14 Participants |
| Risk Factors for Infection Congestive Heart Failure | 450 Participants |
| Risk Factors for Infection Device Replacement/Revision | 377 Participants |
| Risk Factors for Infection Diabetes | 301 Participants |
| Risk Factors for Infection Malignancy | 42 Participants |
| Risk Factors for Infection Malnutrition | 12 Participants |
| Risk Factors for Infection None | 103 Participants |
| Risk Factors for Infection Obesity | 387 Participants |
| Risk Factors for Infection Other | 180 Participants |
| Risk Factors for Infection Peripheral Vascular Disease | 80 Participants |
| Risk Factors for Infection Pocket Re-entry | 5 Participants |
| Risk Factors for Infection Prior Device Infection | 18 Participants |
| Risk Factors for Infection Renal Insufficiency | 115 Participants |
| Risk Factors for Infection Smoker | 121 Participants |
| Risk Factors for Infection Systemic Anticoagulants | 233 Participants |
| Risk Factors for Infection Temporary Pacing | 68 Participants |
| Sex: Female, Male Female | 392 Participants |
| Sex: Female, Male Male | 633 Participants |
| Surgical Glue Used in Procedure No | 677 Participants |
| Surgical Glue Used in Procedure Unknown | 27 Participants |
| Surgical Glue Used in Procedure Yes | 321 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 1,025 |
| other Total, other adverse events | 0 / 1,025 |
| serious Total, serious adverse events | 40 / 1,025 |
Outcome results
Primary
Number of Participants With Major Pocket Infections
Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.
Time frame: Participants were followed for an average of 235.0 days.
Population: Analysis population includes all study participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CanGaroo | Number of Participants With Major Pocket Infections | 12 Participants |
Primary
Proportion of Subjects With ECM Related Adverse Events
ECM related adverse events were collected at all study visits.
Time frame: Participants were followed for an average of 235.0 days.
Population: Analysis population includes all study participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CanGaroo | Proportion of Subjects With ECM Related Adverse Events | Possibly Related to CanGaroo | 14 Participants |
| CanGaroo | Proportion of Subjects With ECM Related Adverse Events | Probably Related to CanGaroo | 2 Participants |